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Infection

, Volume 46, Issue 5, pp 607–615 | Cite as

Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

  • Antonio Ascione
  • Massimo De Luca
  • Mario Melazzini
  • Simona Montilla
  • Maria Paola Trotta
  • Salvatore Petta
  • Massimo Puoti
  • Vincenzo Sangiovanni
  • Vincenzo Messina
  • Savino Bruno
  • Antonio Izzi
  • Erica Villa
  • Alessio Aghemo
  • Anna Linda Zignego
  • Alessandra Orlandini
  • Luca Fontanella
  • Antonio Gasbarrini
  • Marco Marzioni
  • Edoardo G. Giannini
  • Antonio Craxì
  • For the ABACUS Study Group
Original Paper
  • 212 Downloads

Abstract

Purpose

To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years.

Methods

We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12).

Results

Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12.

Conclusion

Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.

Keywords

Cirrhosis Elderly Ombitasvir Paritaprevir Dasabuvir 

Abbreviations

DAAs

Direct-acting antivirals

OBV/PTV/r + DSV

Ombitasvir, paritaprevir, ritonavir + dasabuvir

RBV

Ribavirin

HCV

Hepatitis C virus

GT1

Genotype 1

SVR12

Sustained virological response at 12 weeks after the end of treatment

LC

Liver cirrhosis

HCC

Hepatocellular carcinoma

AIFA

Agenzia Italiana del Farmaco

AISF

Associazione Italiana per lo Studio del Fegato

CTP

Child–Turcotte–Pugh

INR

International normalized ratio

AE

Adverse event

CTCAE

Common terminology criteria for adverse events

ITT

Intention to treat

BMI

Body mass index

eGFR

Estimated glomerular filtration rate

MELD

Model for end-stage liver disease

Notes

Acknowledgements

The ABACUS Study Group: Giuseppe Abbati, Alfredo Alberti, Pietro Andreone, Massimo Andreoni, Paolo Angeli, Mario Angelico, Gioacchino Angarano, Debora Angrisani, Andrea Antinori, Cinzia Antonini, Ivo Avancini, Michele Barone, Raffaele Bruno, Antonio Benedetti, Veronica Bernabucci, Pier Blanc, Chiara Boarini, Nicola Boffa, Lucio Boglione, Vanni Borghi, Guglielmo Borgia, Giuseppina Brancaccio, Maurizia Brunetto, Irene Cacciola, Paolo Calabrese, Vincenza Calvaruso, Davide Campagnolo, Benedetta Canovari, Nicola Caporaso, Franco Capra, Giada Carolo, Giovanni Cassola, Francesco Castelli, Roberto Cauda, Francesca Ceccherini Silberstein, Roberto Cecere, Luchino Chessa, Alessandro Chiodera, Antonio Chirianni, Alessia Ciancio, Serena Cima, Barbara Coco, Massimo Colombo, Nicola Coppola, Giampaolo Corti, Lucio Cosco, Silvia Corradori, Raffaele Cozzolongo, Antonio Cristaudo, Elena Danieli, Antonella D’Arminio Monforte, Marco delle Monache, Paolo Del Poggio, Andrea de Luca, Chiara Dentone, Antonio Di Biagio, Alfredo Di Leo, Giovanni Di Perri, Marco Di Stefano, Giampiero D’Offizi, Francesca Donato, Emanuele Durante, Elke Erne, Stefano Fagiuoli, Katia Falasca, Alessandro Federico, Martina Felder, Carlo Ferrari, Giovanni Battista Gaeta, Roberto Ganga, Pietro Gatti, Vania Giacomet, Andrea Giacometti, Alice Gianstefani, Maria Giordani, Alessia Giorgini, Antonio Grieco, Michele Guerra, Roberto Gulminetti, Donatella Ieluzzi, Michele Imparato, Valentina Iodice, Silvia La Monica, Adriano Lazzarin, Marco Lenzi, Massimo Levrero, Myriam Lichtner, Raffaella Lionetti, Carmela Lo Guercio, Salvatore Madonna, Silvia Magnani, Ivana Maida, Massimo Marignani, Aldo Marrone, Fabio Marsetti, Silvia Martini, Mario Masarone, Renato Maserati, Claudio Maria Mastroianni, Massimo Memoli, Barbara Menzaghi, Manuela Merli, Luca Miele, Michele Milella, Mario Mondelli, Marzia Montalbano, Monica Monti, Olivia Morelli, Filomena Morisco, Gaetano Nardone, Sergio Novara, Giovanna Onnelli, Mirella Onofrio, Simona Paganin, Luca Pani, Maria Rita Parisi, Giustino Parruti, Caterina Pasquazzi, Luisa Pasulo, Carlo Federico Perno, Marcello Persico, Guido Piai, Antonino Picciotto, Grazielle Marie Pigozzi, Sara Piovesan, Maria Chiara Piras, Massimo Pirisi, Anna Maria Piscaglia, Laura Ponti, Domenico Potenza, Cecilia Pravadelli, Mariano Quartini, Tiziana Quirino, Giovanni Raimondo, Gian Ludovico Rapaccini, Maria Rendina, Giuliano Rizzardini, Mario Rizzetto, Salvatore Rizzo, Dante Romagnoli, Antonietta Romano, Cristina Rossi, Maria Grazia Rumi, Maurizio Russello, Francesca Paolo Russo, Maria Luisa Russo, Domenico Ettore Sansonno, Teresa Antonia Santantonio, Giorgio Saracco, Anna Maria Schimizzi, Gaetano Serviddio, Filomena Simeone, Attilio Solinas, Alessandro Soria, Marco Tabone, Gloria Taliani, Giuseppe Tarantino, Pierluigi Tarquini, Marcello Tavio, Antonio Termite, Elisabetta Teti, Pierluigi Toniutto, Carlo Torti, Paolo Tundi, Giacomo Vecchiet, Gabriella Verucchi, Umberto Vespasiani Gentilucci, Maria Vinci, Vincenzo Vullo, Teresa Zolfino, and Massimo Zuin.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no competing interest.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Antonio Ascione
    • 1
  • Massimo De Luca
    • 2
  • Mario Melazzini
    • 3
  • Simona Montilla
    • 3
  • Maria Paola Trotta
    • 3
  • Salvatore Petta
    • 4
  • Massimo Puoti
    • 5
  • Vincenzo Sangiovanni
    • 6
  • Vincenzo Messina
    • 7
  • Savino Bruno
    • 8
  • Antonio Izzi
    • 9
  • Erica Villa
    • 10
  • Alessio Aghemo
    • 11
  • Anna Linda Zignego
    • 12
  • Alessandra Orlandini
    • 13
  • Luca Fontanella
    • 1
  • Antonio Gasbarrini
    • 14
  • Marco Marzioni
    • 15
  • Edoardo G. Giannini
    • 16
  • Antonio Craxì
    • 4
  • For the ABACUS Study Group
  1. 1.Department of Medicine, Centre for Liver DiseaseBuon Consiglio-Fatebenefratelli HospitalNaplesItaly
  2. 2.Liver UnitAORN CardarelliNaplesItaly
  3. 3.Italian Medicines Agency (AIFA)RomeItaly
  4. 4.Department of Gastroenterology, DiBiMISUniversity of PalermoPalermoItaly
  5. 5.Division of Infectious DiseasesAO Niguarda Ca’ Granda HospitalMilanItaly
  6. 6.III U.O.C. P.O. CotugnoAORN Ospedali dei ColliNaplesItaly
  7. 7.Infectious Diseases UnitAORN CasertaCasertaItaly
  8. 8.Humanitas University and IRCCS Clinical Institute HumanitasMilanItaly
  9. 9.Infectious Disease, Cotugno HospitalAORN Ospedali dei ColliNaplesItaly
  10. 10.Gastroenterology Unit, Department of Internal MedicineAOU Policlinico of ModenaModenaItaly
  11. 11.UO Gastroenterology and HepatologyFoundation IRCCS Ca’ Granda Hospital Maggiore Policlinico of MilanMilanItaly
  12. 12.Interdepartmental Centre for Systemic Manifestations of Hepatitis Viruses (MaSVE), Department of Experimental and Clinical MedicineUniversity of FlorenceFlorenceItaly
  13. 13.Unit of Infectious Diseases and HepatologyAOU of ParmaParmaItaly
  14. 14.Internal Medicine, Gastroenterology and HepatologyAgostino Gemelli HospitalRomeItaly
  15. 15.Clinic of Gastroenterology and HepatologyUniversità Politecnica delle MarcheAnconaItaly
  16. 16.Gastroenterology Unit, Department of Internal MedicineUniversity of GenoaGenoaItaly

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